Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

Progressive Multifocal Leukoencephalopathy Clinical Trial

Official title:

Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01211639
• Other study ID #: 101JC403
• Status: Terminated
• Phase: N/A
• First received: September 16, 2010
• Last updated: January 15, 2015
• Start date: October 2010
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to explore host genetic mutations which may render individual subjects more susceptible (or resistant) to developing Progressive Multifocal Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide information about viral genotypes that may be associated with higher pathogenicity, and help to identify individuals who may be at higher risk of developing Progressive Multifocal Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC Virus (JCV).

Description:

Deoxyribonucleic acid (DNA) will be analyzed from natalizumab-treated subjects who develop Progressive Multifocal Leukoencephalopathy (PML). The genetic analysis of the subjects will directly seek mutations that could identify subjects at risk.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Subjects who have confirmed PML while on treatment with Natalizumab

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Leukoencephalopathies
• Leukoencephalopathy, Progressive Multifocal
• Progressive Multifocal Leukoencephalopathy

Locations

Country	Name	City	State
Germany	Research Site	Wuerzburg
United States	Rocky Mountain MS Center at Anschutz Medical Campus University Colorado Denver	Aurora	Colorado
United States	Neurology of Bend, LLC	Bend	Oregon
United States	Rush Medical Center - Rush Multiple Sclerosis Center	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	North Central Neurology Associates	Cullman	Alabama
United States	Central Neurology	Hastings	Nebraska
United States	St. Vincent Hospital, St. Vincent Neuroscience Institute	Indianapolis	Indiana
United States	NYU Hospital for Joint Disease, MS Care Center	New York	New York
United States	Clinical Research Center UH, The Nebraska Medical Center	Omaha	Nebraska
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to examine host genetic variation and possible genetic susceptibility to PML		Up to 3 Months	No
Secondary	To explore predisposing factors of the innate and adaptive immune system		Up to 3 Months	No
Secondary	To analyze DNA sequences of JCV		Up to 3 Months	No
Secondary	optional substudy: to test alterations in DNA repair pathways		Up to 3 Months	No